Swiss Multiple Sclerosis Cohort-Study

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT02433028
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The Swiss MS Cohort Study (SMSC) is a multicentre cohort study that involves 8 Swiss Multiple Sclerosis centres. The key aims of the SMSC are

1. To maintain a long-term cohort for an undefined duration of patients with Multiple Sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD) and Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in Switzerland. This requires effective measures to limit drop-outs and the continuous recruitment of MS patients and

2. To conduct a systematic follow-up with standardized, high quality collection of clinical and magnetic resonance imaging (MRI) data, as well as body fluids.

The significant heterogeneity within the diagnostic entity and phenotype of MS is incompletely understood. A central and necessary prerequisite of further advance is a sufficient amount of high quality clinical and paraclinical (imaging, body fluids) patient data.

Nested projects will address specific research topics, and facilitate collaboration of the most qualified investigators within the group of SMSC investigators. The nested projects will focus on the:

1. Development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response.

2. Exploration of the safety and impact on long-term disability of existing and next generation MS treatments

3. Individualized therapy: A number of highly active but potentially also harmful therapies have lately been established for the treatment of MS. To date, due to the lack of individual prognostic markers patients may not receive aggressive therapy due to safety concerns, or patients with benign disease may receive expensive and potentially harmful treatments without the need for it.

4. Evaluation of intervention effects by conducting embedded pragmatic trials using the SMSC as data-infrastructure.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-05-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-14
• Primary Completion: 2042-01
• Study Completion: 2042-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Fulfilling the diagnosis of radiologically isolated syndrome (RIS), clinically isolated syndrome (CIS), relapsing-remitting Multiple Sclerosis (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), neuromyelitis optica spectrum disorder (NMOSD) or Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) according to established criteria
• Intending to attend hospital visits every 6 months (+/- 45 days) or 12 months (+/- 45 days) (facultative cranial MRI every 12 months) over a longer period (at least 5 years)
• Intending to give blood for biobanking every 6 or 12 months during hospital visit or as close as possible to the visit (+/- 8 days)

Inclusion criteria are crafted to identify a population of patients with MS, NMOSD or MOGAD particularly suitable for analysing disease evolution and associated factors, treatment dynamics, and the long-term safety and efficacy profile of disease-modifying drugs.

There are no specific Exclusion Criteria.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(Optional) Assessment of finger dexterity	Baseline and at each follow-up visit (every 6 or 12 months)	To assess the finger dexterity, the 9-Hole Peg Test is performed. It evaluates manual dexterity by measuring the time it takes for the participant to move nine pegs from a box into nine holes on a board and back. The 9-Hole Peg Test is not mandatory and is performed at the discretion of the physician.
(Optional) Electrophysiological assessment	Baseline and at each follow-up visit (every 6 or 12 months)	To measure the visual, sensory and motor conduction time in the CNS, evoked potential tests are performed. Evoked Potentials are not mandatory and is performed at the discretion of the physician.
(Optional) Laboratory tests	Baseline and at each follow-up visit (every 6 or 12 months)	The following laboratory tests are not mandatory, but are routinely performed in patients with MS at the discretion of the physician: Anti-JCV antibody test; * Anti-natalizumab antibody test; * Lymphocyte count
(Optional) Magnetic resonance imaging	Baseline and at least once per year	The MRI is optional. All MRIs are collected that are done in clinical routine and follow the SMSC MRI protocol.
Assessment of Expanded Disability Status Scale (EDSS)	Baseline and at each follow-up visit (every 6 or 12 months)	Expanded Disability Status Scale (EDSS) is measured using Neurostatus by certified neurologists
Assessment of the quality of life	Baseline and at least once a year	To assess the quality of life, the following patient-reported outcomes are collected: * Multiple Sclerosis Quality of Life-54: A self-report questionnaire regarding quality of life with 36 generic (which corresponds to the 36 items of the Short-Form-36 questionnaire) and 18 MS-specific items.; * EuroQoL-5D: A self-report questionnaire on generic quality of life, with one question for each of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). It also includes a Visual Analog Scale regarding perceived health status, ranging from 0 (worst possible) to 100 (best possible).; * Patient reported questionnaire: Includes questions regarding professional activity and changes, and hospitalization.
Collection of serum and plasma (and, optional) cerebrospinal fluid samples	Baseline and at each follow-up visit (every 6 or 12 months)	Serum and plasma samples will be collected every 6 or 12 months for all participants during study visit. Cerebrospinal fluid samples are facultative and contribute only if the participant is undergoing a diagnostic lumbar puncture.

Trial Locations

Locations (8)

Cantonal Hospital St. Gallen; 🇨🇭 St. Gallen, SG, Switzerland

University Hospital Geneva; 🇨🇭 Geneva, GE, Switzerland

University Hospital Lausanne; 🇨🇭 Lausanne, VD, Switzerland

University Hospital Berne; 🇨🇭 Berne, BE, Switzerland

Univeristy Hospital Zürich; 🇨🇭 Zürich, Switzerland

Cantonal Hospital Aarau; 🇨🇭 Aarau, AG, Switzerland

University Hospital Basel; 🇨🇭 Basel, BS, Switzerland

Regional Hospital Lugano; 🇨🇭 Lugano, TI, Switzerland